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Description

Mass Spectrometry for the Clinical Laboratory is an accessible guide to mass spectrometry and the development, validation, and implementation of the most common assays seen in clinical labs. It provides readers with practical examples for assay development, and experimental design for validation to meet CLIA requirements, appropriate interference testing, measuring, validation of ion suppression/matrix effects, and quality control. These tools offer guidance on what type of instrumentation is optimal for each assay, what options are available, and the pros and cons of each. Readers will find a full set of tools that are either directly related to the assay they want to adopt or for an analogous assay they could use as an example.

Written by expert users of the most common assays found in a clinical laboratory (clinical chemists, toxicologists, and clinical pathologists practicing mass spectrometry), the book lays out how experts in the field have chosen their mass spectrometers, purchased, installed, validated, and brought them on line for routine testing.

The early chapters of the book covers what the practitioners have learned from years of experience, the challenges they have faced, and their recommendations on how to build and validate assays to avoid problems. These chapters also include recommendations for maintaining continuity of quality in testing. The later parts of the book focuses on specific types of assays (therapeutic drugs, Vitamin D, hormones, etc.). Each chapter in this section has been written by an expert practitioner of an assay that is currently running in his or her clinical lab.

Key Features

Provides readers with the keys to choosing, installing, and validating a mass spectrometry platform

Offers tools to evaluate, validate, and troubleshoot the most common assays seen in clinical pathology labs

Explains validation, ion suppression, interference testing, and quality control design to the detail that is required for implementation in the lab

Details

About the Editor

Hari Nair

Dr. Nair received his PhD in 1998 under the advice of Prof. Vicki Wysocki at Virginia Commonwealth University, Richmond, VA with specialization in the study of gas phase dissociation of biomolecules in a mass spectrometer. Since then after an NRC postdoctoral fellowship at the US Army, Aberdeen Proving Grounds, MD he has worked for over a decade in the industry that include the tenures as senior scientist at Applied Biosysems where he participated in the development of novel mass spectrometric instrumentation for biotechnology applications and at Perkin Elmer where he was involved in the development and validation of IVD kits for new born screening and clinical lab testing applications. After completion of fellowship from the Department of Lab Medicine at the University of Washington, Seattle, he received his board certification in Clinical Chemistry by the American Board of Clinical Chemistry in 2014, and is a Fellow of the National Academy of Clinical Biochemistry. After a brief stint as a consultant to toxicology labs, he is currently employed as the technical director at the Boston Heart Diagnostics, Framingham, MA.

Dr. Nair has co-authored several peer reviewed articles, a patent and served as a consulting editor for a med tech text book published by Elsevier.

Affiliations and Expertise

Technical Director, Boston Heart Diagnostics, Framingham, MA, USA

William Clarke

William Clarke received his PhD in Analytical Chemistry from the University of Nebraska in Lincoln in 2000, followed by a post-doctoral fellowship in Clinical Chemistry at the Johns Hopkins School of Medicine, ending in 2002. In addition, he received an MBA focused on Medical Services Management from the Carey School of Business at Johns Hopkins in 2007. He is an Associate Professor in the Department of Pathology, as well as the director of both Point-of-Care Testing and Clinical Toxicology for The Johns Hopkins Hospital. Dr. Clarke is board certified in Clinical Chemistry by the American Board of Clinical Chemistry, and is a Fellow of the National Academy of Clinical Biochemistry. Dr. Clarke has published, as author or co-author, over 100 peer-reviewed manuscripts and book chapters. He is the Editor of the book Contemporary Practice in Clinical Chemistry, and the Co-Editor-in-Chief for the journal Practical Laboratory Medicine.